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On November 25, the Food and Drug Agency (FDA) issued a warning against the use of laparoscopic power morcellators in the management of many women undergoing hysterectomy or myomectomy.
On November 25, the Food and Drug Agency (FDA) issued a warning against the use of laparoscopic power morcellators in the management of many women undergoing hysterectomy or myomectomy.The action followed a review by the FDA and its Obstetrics and Gynecological medical Device Advisory Panel of evidence regarding use of morcellators, which suggested that there was a higher prevalence of unsuspected uterine sarcomas (1 in 352) or leiomyosarcoma (1 in 498) in women undergoing hysterectomy or myomectomy for presumed benign fibroids than the clinical community had previously understood.
In its most recent action, the FDA listed two contraindications to use of the the devices and a “black box” warning that educates women about the potential for dissemination of unexpected malignancy with the laparoscopic power morcellator. Specifically, the FDA issued contraindications for use of the devices in: 1) gynecologic surgery in which the tissue to be morcellated is known to, or suspected to contain malignancy; and 2) removal of uterine tissue containing suspected fibroids in women who are perimenopausal or postmenopausal, or who would be candidates for en bloc tissue removal, (i.e., through the vagina or via a mini-laparotomy). The FDA further advised that providers should thoroughly discuss the risks and benefits of all treatments for uterine fibroids with their patients and inform them that fibroids may harbor unexpected cancers that could be disseminated with the laparoscopic power morcellator and adversely affect their survival.
The laparoscopic power morcellator has facilitated a minimally invasive approach to the surgical management of uterine fibroids, with associated benefits of shorter postoperative recovery time and reductions in surgical infection and bleeding compared with abdominal hysterectomy or myomectomy. Further clarification is needed to establish the appropriate eligibility criteria for use of the power morcellator and additional techniques are being evaluated for contained morcellation with the laparoscopic device.
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